Effect of Alphagan and Xalatan Eye Drops on Corneal Temperature

NCT01201551 — Not applicable, Completed, 40 participants, University Hospital, Basel, Switzerland

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Registry	NCT01201551
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, treatment
Enrollment	40 (Actual)
Sponsor	University Hospital, Basel, Switzerland (Other)
Conditions	Primary Vascular Dysregulation
Interventions	Brimonidine, Latanoprost, Placebo (Drug)
Dates	start 2011-06-01, primary completion 2013-11-01, completion 2013-11-01, first posted 2010-09-14, last updated 2013-12-11
Locations	1 site in Switzerland

-Summary

It is already known that the local treatment with Alphagan eye drops (a drug commonly used by glaucoma patients) reduces ocular blood flow. In-vitro studies suggest that the vasoconstrictive effect of Alphagan is more pronounced when this drug is combined with a prostaglandin analogue (eg. Xalatan eye drops). The investigators also question whether this effect is more pronounced in subjects suffering from a primary vascular dysregulation (PVD). To test for the effect of these drugs on PVD and non-PVD subjects the investigators will take measurements of corneal temperature as surrogate for ocular blood flow.

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+Detailed description

The investigators would like to investigate the effect of Alphagan eye drops, Xalatan eye drops and their combination (both Alphagan and Xalatan) on corneal temperature in healthy subjects with and without a primary vascular dysregulation (PVD).

The investigators would like to answer the following questions:

1. Do the individual drugs influence the circulation to the eye as quantified indirectly via corneal temperature?
2. Does the combination of Alphagan and Xalatan give an additive or even potentiated effect?
3. Is the sequence of application of drugs of relevance (Alphagan applied first, Xalatan second, or vice versa)?
4. Do PVD and non-PVD subjects respond differently to these drugs?

20 healthy non-PVD subjects and 20 healthy PVD subjects in the age range from 20-40 years will be recruited. Recruited subjects will have all measurements: corneal temperature, intraocular pressure (IOP), ear temperature, blood-pressure. Both prior to and after instillation of eye drops (Xalatan, Alphagan and placebo).

+Arms and interventions

Arm	Type	Interventions	Description
healthy subjects without PVD	Active comparator	Drug: Brimonidine; Drug: Latanoprost; Drug: Placebo	healthy subjects without primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo
healthy subjects with PVD	Active comparator	Drug: Brimonidine; Drug: Latanoprost; Drug: Placebo	healthy subjects with primary vascular dysregulation Intervention: Brimonidine, Latanoprost and Placebo

Brimonidine (Drug), also known as Alphagan: Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye
Latanoprost (Drug), also known as Xalatan: Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
Placebo (Drug), also known as Fermavisc: Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye

+Outcome measures

Primary outcomes

Corneal temperature [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]

Secondary outcomes

Intraocular pressure [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]
Ear temperature [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]
Blood pressure [Week 1: day 1 and 2 before eyedrops and after. Week 2: day 1 and 2 before eyedrops and after.]

+Eligibility

Sex: All, ages: 18 Years to 48 Years, accepts healthy volunteers

Inclusion Criteria:

* healthy
* age 18-48 years
* normal findings on ophthalmological examination

Exclusion Criteria:

* history of ocular or systemic disease
* chronic or current systemic or topical medication
* drug or alcohol abuse
* art. hypertension

+Locations (1)

Facility	City	Country	Status
University of Basel, Dept. of Ophthalmology	Basel	Switzerland

+Investigators

Josef Flammer, MD, Study director, University of Basel, Dept. of Ophthalmology